Drug_Development_Final

By Ellie Rest RestEz4@hotmail.com ||  ||
 * **From a Compound to a Drug **

| Instructional Objective]] | [|Learners & Context] | [|Object of Game] | [|Game Materials] | | [|Time Required] | [|Rules] | [|Design Process] | [|References] | After playing this game, the learner will be able to identify the main phases in the drug development process from drug discovery to manufacturing. The learner will have a basic understanding of what happens to a drug in each of the three GxP functional areas: laboratory, clinical and manufacturing. The game will introduce novice players to definitions of terms and concepts, procedures, and processes that relate to the overall drug development process. For players with more expertise, the game will reinforce and build on existing knowledge, challenging these players to learn more about each functional area.
 * Instructional Objective **

After completing the game, learners will also have a general understanding of how regulatory requirements and the FDA affect the drug development and approval process. Finally, learners will be able to list obstacles and identify events that may delay or prevent a drug from being approved by the FDA. __ From a Compound to a Drug __ is designed for female and male adult learners of all ages who do not possess in-depth knowledge of the drug development process. Learners may come from a variety of backgrounds including Sales, finance, human resources and legal. In order to understand how their jobs fit into the company and the overall business process, it is important to understand other functional areas in a pharmaceutical company and the process that drugs go through to reach consumers.
 * Learners & Context of Use **

Since the game is generic and does not describe specific company information, it could be tailored to any audience of novice learners. The game could be played in a new employee orientation, sales training or an Introduction to Drug Development course at a pharmaceutical company. Depending on the number of people in the class, the game could be played with two to four players or in teams of two people with two to four teams. Learners may have different levels of experience and knowledge about the pharmaceutical industry, but the game still has an element of probability (dice and where the player lands) and strategy (collecting safety tokens and answering questions cards) which affects who will wins. If there are employees with more knowledge in drug development, they could be paired with novice learners to balance skills and knowledge. Employees with more knowledge would also have the opportunity to answer “expert” questions versus the “novice” questions, making the questions more challenging.

The game could act as an introduction to drug development by getting learners interested in the various parts of the process. Little knowledge is needed of the drug development process prior to playing the game. Either an instructor or the game’s instructions could describe the general phases of drug development to ensure players understand the goal of the game. The game’s content could be elaborated on with a follow-up class discussion. Learners could talk about what they learned about the drug development process, questions they had, and obstacles they encountered that made it difficult to get a drug approved. ** Object of the Game ** The object of the game is to race other players to the finish line which involves getting your drug compound approved by the FDA so it can be marketed to consumers. A secondary goal is to acquire safety tokens throughout the drug development process. These tokens represent the safety data needed to get a drug approved. A player will need a minimum number of safety tokens to get through each development phase and move to the next level. To get their drug approved, a player must reach the finish line first with a minimum of 4 safety tokens. If the player does not have 4 tokens, the game continues on until that player or another player returns to the finish line with the required number of safety tokens. •   Board •   Laboratory Data Cards •   Laboratory Chance Cards •   Clinical Data Cards •   Clinical Chance Cards •   Manufacturing Data Cards •   Manufacturing Chance Cards •   Dice (1) •   Pawns (drug vials with different color tops) •   Safety tokens Game Board:
 * Game Materials **

The game board is a depicts a linear path through 3 functional areas, Laboratory, Clinical and Manufacturing. The areas are color coded to show each phase of the drug development process. There is a Start line (drug discovery) and a Finish line (FDA approval). Spaces on the path are either blank or have a Question Mark ? representing a Chance Card. Blank spaces represent that the player must draw a Data Card corresponding to that area (either a Laboratory Card, Clinical Card or Manufacturing Card), Chance Card spaces represent that the player must draw a Chance Card corresponding to that area. Data Cards will correspond to the area the player is in (Clinic will have Clinic Data Card). The Color Key on the side of the board summarizes the different functional areas and their color. There are are Safety Check Points Spaces which represent stop points were players must pay the FDA safety tokens to move to the next phase of drug development. The lines between areas represent paths which players must take if they must return to an area to gather more safety tokens.

The front of the Chance Cards will have a Question Mark and state the type of Chance Card (Laboratory, Clincial or Manuaftureing) printed on the color that corresponds to that area on the board. The front of the Data Cards will have an image associated with the functional area and state the type of Data Card (Laboratory, Clincial or Manuaftureing) printed on the color that corresponds to that area on the board.
 * Chance Cards and Data Cards: **

The back of the Chance Cards will state the type of Chance Card (Laboratory, Clincial or Manuaftureing) and will have a command (either Good News or Warning). The command either rewards or punishes the player by giving them an additional safety token or having them move back or forth on the board. This represents random events or obstacles that may occur in this phase of drug development. The back of the Data Cards will list two questions (NOVICE LEVEL or EXPERT Level) depending on the players knowledge. The player will pick the question level and have another player read the question and possible answers. The correct answer is marked on the bottom of the card.

**Pawns**: The players pawns are represented by different color medical vials which represent various drug compounds. The dice will be used to determine the number of spaces the player moves. The pawns will represent the different drug compounds racing for FDA approval. The safety tokens will represent safety data that is needed to get a drug approved by the FDA. Safety tokens are represented by chips. They are rewarded to players who answer a question correctly or who draw a Chance Card that rewards the player tokens. Safety tokens must be paid to the FDA at the “Safety Check” spaces on the board. ** Time Required ** The game will take approximately five minutes to set up. The game will take about an hour to play with 2 to 4 players. If time is limited, players can pick a functional area (lab, clinic or manufacturing) and play from the start to the end of a phase which would take about 20 minutes. This is also an option if the game is played in an adult class that is teaching the drug development process in phases. ** The Rules **
 * Safety Tokens: [[image:chips.jpg width="132" height="117" align="left"]]**
 * The Rules of the Game **

1.  Place the board in the center of the players. 2.  There are six stacks of cards, two sets of cards (Data and Chance cards) for each of the three phases of drug development (Laboratory, Clinical and Manufacturing). Place the two sets of Laboratory Cards to the left of the board near the Lab section of the board, the two sets of Clinical cards at the top of the board near the CLinical section of the board and the two sets of Manufacturing Cards to the right of the board near the Manufacturing section of the board. 3.  Select one player who will distribute and collect the Safety tokens throughout the game. 4.  All Safety tokens are worth 1 point. 5.  Each player should select a medical vile with a different colored top to represent their drug compound and pawn. 6.  All players place their pawns on the Drug Discovery START space on the board. 7.  To determine who goes first, players roll the dice and the highest number goes first. The person to their left of this player will go next and so on until everyone has taken a turn. 8. Decide what level the game should be played at, Novice or Expert. If there are players with various levels of knowledge about drug development, these players may choose to answer Expert questions and beginner players may choose to answer Novice questions. Both question levels are worth one Safety token.
 * Game Setup: **

Drug compounds must go through three phases before they can be submitted to the FDA for approval for use in consumers. These phases are Laboratory, Clinical and Manufacturing. In this game, each player tries to move his or her pawn through each phase of drug development and reach the finish line first. Players must also acquire Safety tokens throughout the game in order to move from one phase to the next so this a secondary object is to aquire as manay Safety tokens as possilbe throughout the game. The player who reaches the finish line (FDA approval) with the required number of Safety tokens first, wins the game.
 * Object of the Game: **


 * How to Play**

10.  The game continues until a player gets to the finish line first with at least 4 safety tokens. This player wins the game and the game ends. ** Design Process ** The first step to my game design was defining a topic and the game scope. I researched other drug development board games and found few games on the topic. Since no games existed on the topic, there was a need for the game in the pharmaceutical industry. While the topic was very general and abstract, the content analysis narrowed the game’s design. The content analysis revealed that there could be a number of possible designs, games, and content around the drug development process. After choosing an appropriate audience and a vantage point for the game, I narrowed the game content to information for novice players. I researched and interview subject matter experts from my company, looked at existing presentations on GLP, GCP and GMP and visited the FDA and PhRMA websites to gather content and ensure the accuracy of my data for the game. This information helped me revise the content analysis for the target audience. Since the vantage point is from a novice to the industry, the content is basic and does not go into great depth about each regulation and law that governs the drug development process. I considered designing a board designed as a pharmaceutical floor plan with different rooms and stations to represent the different functions and processes within the drug development process. I also considered creating a game where different players assumed different roles such as a C.E.O., a lab researcher, a clinical study director, the FDA, but felt that the complexity and the design of this game would be difficult to create in a manageable way and this design would not suite my audience. Using the content from my revised content analysis, I determined the overall game design by mapping the content to different elements in the game. I determined the content on the Data Cards and the overall look and feel for the game. To build the game, I started designing the game in Adobe Illustrator laying out the board itself. I revised the board until the game board conveyed the flow and look that I was happy with. To get feedback on my game idea and prototype, I discussed it with the professor who gave me some insight into how to make varying levels of the game for novices and experts. I also asked colleagues for feedback on the topic. They felt that an introductory drug development game would be unique, interesting and useful to the company, especially in our new employee orientation. After play-testing the game with classmates and friends, I realized that my game was far from finished or ideal. There were many changes and edits, including careless errors such as typos, question card and answer errors, and inconsistencies between the board and rules. There was also confusion about rules, parts of the board and the original game function and design. During the play-testing, I took notes. I learned ways to make the game more streamlined and clear. I revised the game design and rules using the feedback from the play-testing. This included, re-coloring sections of the board to make the three functional areas visually more clear. I added an Expert and Novice question to each card since my original idea to have Experts answer questions without hearing possible answers did not work with play-testers. I also changed the number of safety tokens required at the Safety Check Point spaces since players expressed frustration and thought the barriers were too high in the game which decreased the level of fun and motivation they felt. I changed the Game Rules to streamline them and added instructions where play-testers were confused. I also took out the element where players could assign Data Cards to other players since this was not utilized with play-testers and they seemed unclear about how to use this portion of the game. This element did not add anything to the game or the learning experience and seemed like an unnecessary piece that could be removed to make the game more playable. After making multiple revisions, the game needs to be play-tested with the intended audience members and revised further which will take time. From this overall experience of creating a board game, I learned how to do a content analysis, map elements from the analysis to the game content and play-test. Next time, I would play-test the game in an earlier stage and invest less time in creating the actual prototype. The play-testing process was very helpful. I learned a lot about the game by just watching the players stumble through it. It made it clear what needed to be revised and what was unclear. The interviews with play-testers after the game also gave me fresh and creative ideas about how to present materials, content and design the game to make it more playable. It found it difficult to not interject during the play-test and explain something, but it was necessary in order to get a real idea if people could play the game without me present. I found the rubric on game design to be very helpful in directing how to think about a board game and how to improve my own game design. Through this experience, I have learned that games need to be tested various times with different audiences. Feedback is necessary to make a game playable and clear so everyone has the same interpretation of the rules and the game. Game design and development is a complicated process that takes time and constant evaluation. Without feedback and incorporating the feedback into the design, the game would not be playable or clear.
 * 1)  On a player’s turn, the player will roll the dice and move the number of spaces shown. If there is a break in the path, the player may choose the direction his or her pawn moves.
 * 2)  The person to the right of the player draws a Data Card or a Chance Card from the top of the pile for the player. The Data Card or Chance Card should correspond to the area the player’s pawn is in. So, if the player's pawn is in the laboratory area, a **Laboratory Data Card** or **Laboratory Chance Card** is drawn.  *  For a Data Card, the person reads the question and possible answers. The question is either Novice or Expert level depending on what was determined prior to the game.
 * The player answers the question. If he or she answers right, he or she is awarded 1 safety token. If he or she answers wrong, the card holder reads the correct answer and discards the card.
 * For a Chance Card, the person reads the instructions on the Chance Card and the player must follow them.
 * The game moves to the next player's turn on so on.
 * Players must stop at the **Safety Check spaces** on the board between each drug development phase even if the dice roll is past the Safety Check point.
 * Players must give the banker the number of safety tokens specificied on the Safety Check Space on the board, then wait for his or her next turn to continue on. He or she may keep additional safety tokens to use in the next level.
 * If a player does not have the required number of Safety tokens, he or she must follow the instructions on the space :
 * Laboratory Safety Check: player must wait in the Clinical Hold space and roll a 1, 2, or 3 on his or her turn to move on. If he or she does roll a 1, 2, or 3, the player moves to the space to the left of the clincial hold area and waits for his or her next turn to move.
 * Clinical Safety Check: player must follow the line backwards and start from that space on the board on his or her next turn.
 * Manufacturing Safety Check: player must follow the line backwards and start from that space on the board on his or her next turn.

What did you look at to inform your design of the game? ·  Books & Journals •  Csikszentmilalyi, M. (1990). Flow: The Psychology of Optimal Experience. “// The Conditions of Flow. //” HarperCollins: p.71-93. •  Jonassen, D. (1988). Instructional Designs for Microcomputer Courseware. // “Use of the ARCS Motivation Model in Courseware Design //” by Keller, John and Katsuaki Suzuki. Lawrence Erlbaum Associates, Inc.: p.401-434. o   http://en.wikipedia.org/wiki/Main_Page o  http://www.phrma.org/ o  http://www.fda.gov/ o http://www.pharmexeceurope.com/europharmexec/Articles:+Corporate+Strategy/Do-Your-Key-Employees-Understand-RampD-Business/ArticleStandard/Article/detail/473715?contextCategoryId=42729 ||
 * References**
 * Books & Journals **
 * Electronic **